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NCT03063268 · ClinicalTrials.gov registry record · NA
An Interactive Patient-Centered Consent for Research Using Medical Records
A NA study, sponsored by University of Florida.
- Completed
- Registry status
- NA
- Development phase
- 734
- Enrollment target
NCT03063268: Completed NA study, sponsored by University of Florida.
NCT03063268 is a NA study that has completed, run by University of Florida. The registered enrollment target is 734 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03063268, a NA study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- NA
- Development phase
- 734 participants
- Enrollment target
Study Summary
The goal of this project is to develop and evaluate a novel, electronic informed consent application for research involving electronic health record (EHR) data. In response to NIH RFA-OD-15-002, this study addresses research using clinical records and data, including the issues of the appropriate content and duration of informed consent and patient preferences about research use of clinical information. This study will design an electronic consent application intended to improve patients' satisfaction with and understanding of consent for research using their EHR data. The electronic application will provide interactive functionality that creates a virtual, patient-centered discussion with patients about research that uses EHR data. Also, to correct potential misconceptions and increase informedness, the application will present trust-enhancing messages that highlight facts about research regulations, researcher training, and data protections. This study (Specific Aim 2 of the linked study protocol) will compare the effectiveness of the interactive, trust-enhanced consent application to an interactive consent and standard consent (no interactivity, no trust- enhancement) using a randomized trial of the three consents with 750 adults in a network of family medicine practices. Primary outcomes will be satisfaction with the consent decision and understanding of the consent content. This application will allow patients to learn more about clinical research and make informed choices about whether or not they want their health records and data to be used for research. This first phase of this project (IRB#:201500678) was innovative because it created a virtual, patient-centered discussion about research using EHR data. Moreover, this project produced a consent application that clinicians and researchers will use in this phase (Phase two) of the trial as an ethically sound and practical tool for consenting patients, in a clinical setting, for research involving EHRs. Overa
Primary Outcome
Satisfaction With Decisions scale (Holmes-Rovner et al. 1996); 6-items, 5-point Likert scale (strongly disagree-strongly agree)
Interventions
- BEHAVIORAL Trust-Enhanced Messaging on E-Consent
- BEHAVIORAL Interactive features on E-Consent
- BEHAVIORAL Standard E-Consent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 734 participants |
| Start Date | 2017-11-06 |
| Est. Completion | 2019-08-09 |
| Phase | NA |
What the finished NCT03063268 record still lists
NCT03063268 is an interventional study that assigns participants to a tested intervention. The registered 734 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 3 interventions - of which Trust-Enhanced Messaging on E-Consent is the first listed.
NCT03063268 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03063268 about?
NCT03063268 is a clinical study titled "An Interactive Patient-Centered Consent for Research Using Medical Records". The goal of this project is to develop and evaluate a novel, electronic informed consent application for research involving electronic health record (EHR) data. In response to NIH RFA-OD-15-002, this study addresses research using clinical records and data, including the issues of the appropriate co...
What is the current status of trial NCT03063268?
This trial is currently completed. It is a NA study. The enrollment target is 734 participants. The study started on 2017-11-06. Estimated completion is 2019-08-09.
What interventions are being tested in trial NCT03063268?
The interventions under investigation include: Trust-Enhanced Messaging on E-Consent (BEHAVIORAL), Interactive features on E-Consent (BEHAVIORAL), Standard E-Consent (BEHAVIORAL).
Who is sponsoring clinical trial NCT03063268?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03063268's enrollment target sits among peer trials
734 145th of 2000 higher than 1,856 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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